Methods for Medication Administration

ABSTRACT

Apparatuses and methods for medication administration via a body cavity. In one aspect, a medication administration device includes: a tip portion having a plurality of holes and a balloon defining a balloon cavity. When the balloon is deflated the tip portion can be inserted into a body cavity, such as rectum, to allow medication delivery through the holes in the tip portion. When inflated, the balloon can prevent the tip portion from being withdrawn from the body cavity and/or hold dispersed medication within the body cavity. The device further includes a port portion that has a first port and a second port, and an elongated tubular portion that is coupled between the tip portion and the port portion. The tubular portion has a first lumen connecting the first port to the plurality of holes in the tip portion, and a second lumen connecting the second port to the balloon cavity.

RELATED APPLICATIONS

The present application claims priority to the provisional U.S. PatentApplication Ser. No. 60/998,286, filed Oct. 10, 2007 and entitled“Rectal Medication Administration Tube”, and to the non-provisional U.S.patent application Ser. No. 12/609,014, filed on Sep. 23, 2008, andentitled “Apparatuses and methods for Medication Adminitration”, thedisclosure of which is hereby incorporated herein by reference.

FIELD OF THE TECHNOLOGY

At least some embodiments of the disclosure relate to delivery ofmedications in general and, more particularly but not limited to,delivery of medication into rectum.

BACKGROUND

Most patients lose the ability to swallow at a certain point near death,during which symptom management can become challenging, as symptoms,such as pain, shortness of breath, restlessness or agitation, tend toworsen.

The rectum is a good alternative for hospice patients when the oralroute fails. The walls of the rectum absorb many medications fast andeffectively.

Traditional forms of rectal administration use suppositories and/or gelsthat are injected using a pre-filled syringe. These traditionalapproaches typically involve moving or repositioning the patient, whichis many times uncomfortable and invasive for the patient and difficultfor the caregivers. Such a process can be painful, especially if thepatient has hemorrhoids.

SUMMARY OF THE DESCRIPTION

Apparatuses and methods for medication administration via a body cavityare described herein. Some embodiments are summarized in this section.

In one aspect, a medication administration device includes: a tipportion having a plurality of holes and a balloon defining a ballooncavity. When the balloon is deflated the tip portion can be insertedinto a body cavity, such as rectum, to allow medication delivery throughthe holes in the tip portion. The balloon is configured to prevent thetip portion from being withdrawn from the body cavity and, in at leastsome embodiments, to hold medication within the rectum after the balloonis inflated inside the body cavity. The device further includes a portportion that has a first port and a second port, and an elongatedtubular portion that is coupled between the tip portion and the portportion. The tubular portion has a first lumen and a second lumen. Thefirst lumen connects the first port to the plurality of holes in the tipportion; and the second lumen connects the second port to the ballooncavity.

In one embodiment, the tip portion is configured to be inserted intorectum; the diameter of the first lumen connecting the first port to theplurality of holes is no more than 3 millimeters to limit a volume ofthe first lumen; and the volume of the first lumen is no more than 4milliliter to reduce medication dilution after medication is flushed outof the first lumen into the body cavity through the holes in the tipportion.

In one embodiment, the elongated tubular portion is sufficient toconnect the port portion to a front of portion of a patient while thetip portion is engaged within the rectum of the patient.

In one embodiment, the holes are configured to allow a limited amount ofmedication to be evenly distributed to an area of the rectum whenmedication is pressured through the first lumen via the first port.

In one embodiment, the tip of the tip portion is closed.

In one embodiment, when the balloon engages rectal sphincter, the holesin the tip portion are positioned at a distal portion of the rectum.

In one embodiment, the outer diameter of the tubular portion is between5.5 to 7 millimeters; the diameter of the first lumen is 3 millimeters;a diameter of the second lumen is less than 1 millimeter; a distancebetween a tip of the tip portion and a center of the balloon is between2.5 to 3.5 inches; a diameter of the holes is between 1.5 to 2millimeters; and spacing between the holes is between 4 to 6millimeters.

In one embodiment, the first and second ports are configured tointerface with a syringe. The first and second ports are configured toclose when syringes are withdrawn from the first and second ports. Forexample, each of the first and second ports may include a lock connectorand valve.

In another aspect, a medication administration device includes: a tipportion having a plurality of holes and a balloon defining a ballooncavity. When the balloon is deflated the tip portion can be insertedinto rectum to allow medication delivery through the holes in the tipportion. The balloon is configured to prevent the tip portion from beingwithdrawn from the rectum after the balloon is inflated inside therectum. The holes are distributed in the tip portion to delivermedication in a solution form or a suspension form to a distal portionof the rectum. The medication administration device further includes aport portion that has a first port and a second port. Each of the firstand second port has a Luer lock connector with a valve, where the valveopens when a common Luer lock syringe is inserted and closes when thesyringe is withdrawn. The medication administration device furtherincludes an elongated tubular portion coupled between the tip portionand the port portion. The tubular portion has a first lumen and a secondlumen, where the first lumen connects the first port to the plurality ofholes in the tip portion, and the second lumen connects the second portto the balloon cavity.

In a further aspect, a method includes: providing a device having a tipportion, a port portion and an elongated tubular portion coupled betweenthe tip portion and the port portion. The tip portion has a plurality ofholes and a balloon. The port portion has a first port connected by afirst lumen in the tubular portion to the holes in the tip portion, anda second port connected by a second lumen in the tubular portion to thetip portion to inflate or deflate the balloon. The method furtherincludes: inserting the tip portion of the device into the rectum of apatient while the balloon is deflated; inserting a first syringe intothe second port to inject a predetermined amount of water into theballoon to inflate the balloon; removing the first syringe from thesecond port; inserting a second syringe into the first port to injectmedication in a liquid form or a suspension form into the first lumenfor dissemination in a distal portion of the rectum; and removing thesecond syringe from the first port until a next scheduled medicationtime.

In one embodiment, the method further includes: injecting apredetermined amount of water into the first lumen to flush medicationsfrom the first lumen into the distal portion of the rectum; inserting anempty syringe into the second port to remove water from the balloon todeflate the balloon; and removing the tip portion of the device from therectum after the balloon is deflated.

In one embodiment, the method further includes periodicallydisseminating medication to the distal portion of the rectum through thefirst port without removing the tip portion of the device from therectum.

Other features will be apparent from the accompanying drawings and fromthe detailed description which follows.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments are illustrated by way of example and not limitation inthe figures of the accompanying drawings in which like referencesindicate similar elements.

FIG. 1 shows a device for medication administration according to oneembodiment.

FIG. 2 shows a cross section of the device illustrated in FIG. 1.

FIG. 3 shows a cross section of a tip portion of the device illustratedin FIG. 1.

FIG. 4 shows an alternative device according to one embodiment.

FIG. 5 illustrates the use of a device for medication administration inrectum according to one embodiment.

FIG. 6 shows a method to use a device to deliver medication according toone embodiment.

DETAILED DESCRIPTION

The following description and drawings are illustrative and are not tobe construed as limiting. Numerous specific details are described toprovide a thorough understanding. However, in certain instances, wellknown or conventional details are not described in order to avoidobscuring the description. References to one or an embodiment in thedisclosure are not necessarily references to the same embodiment; and,such references mean at least one.

One embodiment of the disclosure provides a device for medicationadministration, which allows for comfortable administration ofmedication in a liquid form. The medication could be either in solution,such as intravenous preparations, or in suspension, such as medicationswhich are crushed and added with water, or another solvent or liquid.

Although some embodiments are described in the context of rectalmedication administration, the devices can also be used in otherapplications.

In one embodiment, a device for rectal medication administrationincludes a medication administration port connected to a tube to carrythe medication into the rectum. There are a number of small holes at theend of the tube to disperse the medication onto the rectal mucosa.

In one embodiment, the end of the tube is ballooned, which when inflatedin the rectum holds the end of the tube in the rectum for ongoingmedication administration. For example, since the end of the tube isheld in place, medication can be given intermittently or continuously onan ongoing basis. In one embodiment, the medication administration portcloses automatically when the syringe is removed, allowing formedications to be given intermittently. The medication port can also beused for continuous infusion. For example, intravenous tubing can beattached to the medication administration port for a continuous infusionrectally.

Alternatively, the end of the tube is not ballooned; and the device canbe configured for single use.

FIG. 1 shows a device for medication administration according to oneembodiment. The device 100 illustrated in FIG. 1 can be used foradministering medications into rectum.

In FIG. 1, the device 100 has a hollow tube 103. In one embodiment, thetube 103 is about 15-17 inches long with a diameter of 18 French (6mm)., but it may have different sizes in different embodiments. The tube103 may be made of any of several different soft, flexible, bio-safematerials, for example, latex, silicone, or soft plastic. The tube 103provides a path for the medication to travel from a medicationadministration port 102 to the tip portion of the tube 103.

In one embodiment, the tip portion of the tube 103 is to be placed inthe rectum of the patient, human or other animal. The tip portion of thetube 103 has two holes for the medicine to pass into the rectum in oneembodiment, but have more holes in other embodiments.

In FIG. 1, the tip portion of the tube 103 includes a balloon 104 and anoptional marker 108 which is a guide for depth of placement of the tipportion of the tube 103 (e.g., for placement in rectum).

In one embodiment, the marker 108 is a black line 3 inches way from theend of the tube. In other embodiments, the marker 108 may be 3 to 4.5inches way from the end of the tube. The marker 108 can be placed at alocation based on the desired length of the tip portion that is to beinserted into the rectum.

In one embodiment, the tube is long enough to allow the medicationadministration port to be brought around to the front of a humanpatient, either between the legs, or around the buttocks, allowingaccess to the port without moving the patient, although this may not bethe only reason or use for the length of the tube.

The tip portion of the device illustrated in FIG. 1 may be left in therectum for an indefinite period of time to allow ongoing medicationadministration without the discomfort of having to pass through therectal sphincter with each dose. The tube stays in place by inflation ofa balloon 104 on the inside of the rectum, just past the rectalsphincter in most cases.

In one embodiment the balloon has a 10 milliliters capacity, but mayhave more or less capacity, or may not be present at all in someembodiments. In one embodiment, when fully inflated, the balloon has adiameter approximately one inch.

The balloon can be made of a material which is pliable enough to passthrough the rectal sphincter with ease should defecation occur. In thiscase, the balloon could be deflated, the tube reinserted and the balloonre-inflated.

The device 100 illustrated in FIG. 1 has a balloon inflation port 101which opens when a syringe is attached and closes when removed, whichallows the balloon to be inflated and deflated as needed, for instance,if the patient needed to defecate or the tube was no longer needed. Theballoon can be inflated by injecting the volume of liquid needed intothe port 101. This fluid travels through a balloon inflation lumen 107(illustrated in FIG. 2) inside the tube 107, which runs along side themedication lumen 106 (illustrated in FIG. 2).

The technology for both the balloons and ports are in existence in manyforms and are extensively used in human and veterinary medicine today.

FIG. 2 shows a cross section A-A′ of the device illustrated in FIG. 1.The cross section A-A′ illustrated in FIG. 2 is substantiallyperpendicular to the longitudinal axis of the tube 103. The crosssection A-A′ of the device shows the medication lumen 106, separate fromthe balloon inflation lumen 107. The medication lumen 106 provides apath for medications to travel from the medication—port 102 to the holes105 in the tip portion of the tube 103. The balloon inflation lumen 107provides a path for balloon inflation liquid, such as water, to travelfrom the balloon inflation port 101 into the cavity of the balloon 104.

FIG. 3 shows a cross section of a tip portion of the device 100illustrated in FIG. 1. The cross section illustrated in FIG. 3 issubstantially along the longitudinal axis of the tube 103.

In one embodiment, the tip 123 of the device 100 is closed, asillustrated in FIG. 3. Alternatively, the tip 123 of the device 100 mayalso have one or more small holes (e.g., a hole having a diametersmaller than the diameter D₂ of the main, medication lumen 106).Alternatively, the tip 123 of the device 100 may be open (e.g., with ahole having a diameter substantially the same as the diameter D₂ of themain, medication lumen 106). However, tips that are partially orcompletely open may be clogged by stool and/or may cause discomfort tothe patient during insertion.

In FIG. 3, the balloon inflation lumen 107 connects to the ballooncavity 121. The balloon 104 is inflated when a balloon inflation liquid,such as water, is injected into the balloon cavity via the ballooninflation lumen 107 (and via the balloon inflation port 101). Theballoon 104 is inflated by the water injected into a cavity separatefrom the medication lumen 106 of the tube 103 through which themedication travels.

In one embodiment, the tip portion of the device 100 has a multiplicityof—transmission holes 105, which allow a specific injected amount ofliquid, carrying the medication, to be distributed to as large a surfacein the distal rectum as possible (without having to fill up the rectum).In some embodiments, the transmission holes 105 are configured to have apattern and/or orientation to target the application of the medicationto a specific area to which the holes are pointing to.

In one embodiment, to apply the medication to a distal ⅓ portion ofrectum, the tip portion has a length L_(T) between 2.5 to 3.5 inchesfrom the tip 123 to the center of the balloon.

In one embodiment, the diameter d of the balloon inflation lumen isabout 1 millimeter; and the diameter D₂ of the main, medication lumen106 is no more than 3 millimeters (e.g., having a diameter of 2millimeters) to limit the volume of medication lumen. In one embodiment,the volume of the medication lumen is less than 4 milliliters (e.g., 3milliliters) to limit the amount of dilution caused by flushing themedication out of the medication lumen 106 and into the patient.

For example, after the medication is injected into the medication port102, a portion of the medication remains in the medication lumen 106. Apredetermined amount of water, preferably equal to the volume of themedication lumen 106 can be injected into the medication port 102 toflush the medication out of the medication lumen 106. The water stays inthe medication lumen 106 would dilute the medication applied at the nextmedication time. Thus, limiting the volume of the medication lumen 106can limit the dilution caused by the water used to flush the medicationout of the medication lumen 106 and into the patient. Secondly, limitingthe overall flush volume reduces discomfort caused by large volumes ofliquid stimulating the rectal smooth muscle.

In one embodiment, the outer diameter D₁ of the tube is between 5.5 to 7millimeters (e.g., 6 millimeters).

In one embodiment, the diameter of the transmission holes 105 is between1.5 to 2 millimeters; and spacing between the holes is between 4 to 6millimeters (e.g., 5 millimeters).

FIG. 4 shows an alternative device according to one embodiment. Thedevice illustrated in FIG. 4 does not have a balloon. The optionalmarker 108 is used as a guide of placement. The device has a medicationport 201, which connects to the transmission holes 203 by a lumen in thedevice running from the port 201.

The device can be configured as a single use device. The deviceillustrated in FIG. 4 allows for administration of medication withoutleaving the tip portion of the device in the rectum. The use of lessmaterial makes the device illustrated in FIG. 4 more cost effective ifit is not necessary to keep the tip portion of the device in rectum forperiodic medications, or for continuous infusion.

In one embodiment, the device as illustrated in FIG. 4 is four incheslong and 16 Frenches in diameter, but may be other lengths or diametersin other embodiments. The material it is made of would be stiff enoughto insert into the rectum without bending on itself, but pliable enoughthat it could not penetrate the rectal wall.

In one embodiment, a line marked around the entire diameter of the tubeis about 2.5 to 3 inches from the tip, to indicate the depth ofinsertion into the rectum, but this may or may not be present in otherembodiments.

When the device illustrated in FIG. 4 is used, medication can beadministered through the self closing port 201, which is similar to theport 101 of the device 100 illustrated in FIG. 1. The medication can begiven via syringe in most cases, but could be any device with a standardsyringe tip or Luer lock tip. The medication travels through the tube,into the rectum, and is released in the rectum through small holes 203in the last inch of the tube 203.

In one embodiment, the diameter of the inner lumen of the tube is 1.5millimeters, leaving a very small amount of medication in the lumen ofthe tube after administration, thus avoiding the need to flush thedevice after medication administration in most cases.

Alternatively, the tip portion that has the transmission holes 203 maybe left in the rectum for a period of time for ongoing medications.

FIG. 5 illustrates the use of a device for medication administration inrectum. In FIG. 5, the balloon 104 is inflated to keep the tip portionof the device 100 in the rectum 131, after the tip portion is insertedpassed the rectal sphincter 133. The device 100 has a length sufficientlong to allow the ports 101 and 102 be brought to a convenient locationfor medication administration, while the patient can be in a comfortableposition to receive medication. Thus, repeated application of medicationwould be less intrusive, less discomfort for the patient and would beeasier for the caregivers

As illustrated in FIG. 5, the transmission holes 105 in the tip portionof the device 100 allow the application of the medication to be targetedat a specific portion of the rectum 131 (e.g., a distal portion of therectum)

FIG. 6 shows a method to use a device to deliver medication according toone embodiment. In FIG. 6, after the rectum is cleared 301, lubricationof the tip portion of the device is performed 303, using a lubricant,such as water based lubricants. The device has a first port and a secondport. After the tip of the device is inserted 305 into the rectum, asyringe can then be attached 307 to the second port of the device toinject 309 a predetermined amount of a liquid through the second port toinflate the balloon of the device.

After the balloon is inflated within the rectum, the syringe can bewithdrawn 311 from the second port of the device. The valve in thesecond port of the device closes to keep the balloon inflated after thesyringe is withdrawn.

At a medication time, a syringe is attached 313 to the first port of thedevice to inject 315 a predetermined amount of medication through thefirst port for the delivery of medication into the rectum. Then thesyringe is withdrawn 317 from the first port of the device.

To flush the medication lumen of the device, a syringe can be attachedto the first port 319 to inject a predetermined amount of a liquid, suchas water, through the first port. The syringe can then be withdrawn 323from the first port of the device; and the tip portion of the device canbe left inside the rectum for next medication time 325.

Operations 313 through 323 can be performed again at the next medicationtime without having to move or turn the patient.

Securing the tip portion in the rectum using the balloon and allowingthe patient to be in a comfortable position while the medication isapplied allow the medication administration be performed over aprolonged period of time. For example, the medication may be applied ata slow continuous rate for a period of time. Alternatively, themedication can be applied periodically (e.g., once every four hours, sixhours, twelve hours, etc.)

When the device 100 as illustrated in FIG. 1 is used, the patient doesnot have to endure the pain and embarrassment of repeated rectalinvasion. A patient's current medications can continue to be giveneasily and effectively when the oral route fails. The device is easy toplace, and is easy use by the caregiver. It is easy to replace if it isexpelled during defecation. It does not normally cause discomfort anddoes not stop the passage of stool.

It will be apparent to a skilled artisan that the embodiments describedabove are exemplary. There could be many alterations made to theseexamples without departing from the spirit and scope of the invention.For example, different devices could be many different lengths ordiameter sizes. The lumen diameters may be different. The devices couldbe made of many different materials. The devices may or may not havemarkings to guide insertion depth. The devices may have self closingvalves with different technology than that demonstrated. The devices mayor may not have balloons. These and many other features may change indifferent embodiments of the devices.

In the foregoing specification, the disclosure has been provided withreference to specific exemplary embodiments thereof. It will be evidentthat various modifications may be made thereto without departing fromthe broader spirit and scope as set forth in the following claims. Thespecification and drawings are, accordingly, to be regarded in anillustrative sense rather than a restrictive sense.

1. A method, comprising: providing a device having a tip portion, a portportion and an elongated tubular portion coupled between the tip portionand the port portion, the tip portion having a plurality of holes and aballoon, the port portion having a first port connected by a first lumenin the tubular portion to the holes in the tip portion, the port portionhaving a second port connected by a second lumen in the tubular portionto the tip portion to inflate or deflate the balloon; inserting the tipportion of the device into rectum of a patient while the balloon isdeflated; inserting a first syringe into the second port to inject apredetermined amount of water into the balloon to inflate the balloon;removing the first syringe from the second port; inserting a secondsyringe into the first port to inject medication in a liquid form or asuspension form into the first lumen for dissemination in a distalportion of the rectum; and removing the second syringe from the firstport until a next scheduled medication time.
 2. The method of claim 1,further comprising: injecting a predetermined amount of water into thefirst lumen to flush medications from the first lumen into the distalportion of the rectum.
 3. The method of claim 2, further comprising:inserting an empty syringe into the second port to remove water from theballoon to deflate the balloon; and removing the tip portion of thedevice from the rectum after the balloon is deflated.
 4. The method ofclaim 1, further comprising: periodically disseminating medication tothe distal portion of the rectum through the first port without removingthe tip portion of the device from the rectum.